Reported May 21, 2025 · Ongoing
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 32 3rd Ave · Burlington, MA · 01803-4414
Is this the product you have?
- Pruitt Occlusion Catheter
- Catalog Numbers
2103-362103-462103-56E2103-36E2103-46E2103-56
- Lot codes and dates
- UDI-DI
0084066310153500840663101542
- Catalog Numbers
2103-362103-462103-56E2103-36E2103-46E2103-56. Lots
- not expired with the following prefixPOC, QPO, XPO
- UDI-DI
- Amount recalled
- 65,977 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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